Clinical Research Associate II – Oncology

🔥 12 hours ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

💵 $78.5k - $141k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Advance AbbVie’s oncology clinical research pipeline and turn scientific discoveries into medicines • Serve as the primary point of contact for investigative sites • Provide contextual information on clinical trials and connect stakeholders with investigative sites • Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles • Conduct site evaluation, site training, routine monitoring, and site closure monitoring • Ensure compliance with protocols, monitoring plans, regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, and quality standards • Customize site engagement strategies and use CRM tools to report progress and measure impact • Support clinical trial execution, patient recruitment, retention, and protocol compliance • Mentor and train less experienced CRAs and contribute to their development • Participate in global or local task forces and initiatives • Conduct continuous risk assessment with the Central Monitoring team to identify study performance and patient safety issues • Implement preventative and corrective action plans to mitigate risks and promote compliance • Identify, evaluate, and recommend investigators and clinical trial sites • Ensure data quality, timely data submission, safety-event reporting, and follow-up • Maintain audit and regulatory inspection readiness at assigned sites • Manage investigator payments according to executed contracts, as applicable

🎯 Requirements

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred • Minimum of 1 year of clinically related experience • At least 6 months of clinical research monitoring experience for investigational drug or device trials • Familiarity with risk-based monitoring, including onsite and offsite monitoring • Knowledge of therapeutic area indications preferred • Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Strong cross-functional collaboration skills • Strong planning and organizational skills • Ability to work effectively in a dynamic environment with competing projects and deadlines • Ability to leverage technology, tools, and resources for customer-centric site support • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish site relationships and trusted partnerships through engagement, motivation, and training • Critical thinking and good judgment to address clinical site issues • Ability to act with integrity in accordance with AbbVie’s code of business conduct and leadership values • Self-motivated and focused on timely, quality outcomes in a fast-paced environment

🏖️ Benefits

• Paid time off, including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in short-term incentive programs